{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"}],"units":"Participants"}],"description":"The following qualify as dose limiting toxicities:\n\n* Grade 3 or greater non-hematologic toxicity, considered by the investigator to be related to study drugs.\n* Grade 4 hematologic toxicity defined as: thrombocytopenia with platelets \\<10,000 µ/L on more than one occasion despite transfusion support; grade 4 neutropenia occurring for more than 7 days and/or resulting in neutropenic fever with elevated temperature (defined as \\> 101 degrees F). Lymphopenia, a recognized side effect of bortezomib, is not considered a DLT.\n* Inability to receive Day 1 dose for Cycle 2 due to toxicity","groups":[{"description":"Combination of everolimus \\& rituximab for 6 cycles\n\nEverolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)","id":"OG000","title":"Phase I Stage A Level 1"},{"description":"Combination of everolimus \\& rituximab for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)","id":"OG001","title":"Phase I Stage A Level 2"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG002","title":"Phase I Stage B Level 1"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG003","title":"Phase I Stage B Level 2"}],"paramType":"NUMBER","populationDescription":"In Phase I Stage B Level 1, one participant was replaced as an exception granted to the principal investigator having experienced a dose delay due to an adverse event not deemed a DLT.","reportingStatus":"POSTED","timeFrame":"Assessed within the first cycle (28 days) of the study.","title":"Everolimus Dose Limiting Toxicity (DLT) [Phase I]","type":"PRIMARY","unitOfMeasure":"participants"}